Recalls / Class III
Class IIID-0260-2021
Product
Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.
- Affected lot / code info
- Lots #: CDKSN, CDPPH, Exp January 2022; Lot #: CDPPK, Exp February 2022.
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Akebia Therapeutics dba Keryx Biopharmaceutials, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 245 1st St, N/A, Cambridge, Massachusetts 02142-1200
Distribution
- Quantity
- 17,664 bottles
- Distribution pattern
- Nationwide.
Timeline
- Recall initiated
- 2021-01-29
- FDA classified
- 2021-02-17
- Posted by FDA
- 2021-02-24
- Terminated
- 2022-02-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0260-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.